A vibrant EU pharmaceutical sector is essential to achieving a high level of public health protection and a competitive knowledge-based economy. In 2012, the sector was worth EUR 220 billion and employed about 800,000 people – around 1.8% of the EU’s total manufacturing workforce. The pharmaceutical sector also has one of the highest labour productivities in the EU. Today, the sector is extensively regulated at EU level in order to protect public health and strengthen the industry’s competitiveness through the continued development of a single EU market for pharmaceuticals.

Commission actions

Since the adoption of the first legislation for the sector in 1965, the EU has enacted various other pieces of legislation with the aim of achieving a single market for pharmaceuticals that also guarantees a high level of protection for public health.

Medicinal products for human use and veterinary use

All medicinal products for human use must be authorised at national or EU level before they can be placed on the EU market. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines, and clinical trials. The EU has established the European Medicines Agency (EMEA) to help in this process by coordinating the scientific evaluation of the quality, safety, and efficacy of medicinal products undergoing an authorisation procedure.

Once a medicinal product has been authorised and placed on the EU market, its safety is monitored throughout its entire lifespan. In the case of adverse reactions that present an unacceptable level of risk under normal conditions of use, the product is rapidly withdrawn from the market. This is done through the EU system of pharmacovigilance.

Medicinal products for veterinary use must also be authorised at national or EU level before being placed on the EU market. This is to guarantee the highest possible level of animal health and to secure the availability of these products across the EU. Particular special rules are applied to ensure consumer protection from residue limits from pharmacologically active substances used in food-producing animals.

Ensuring competitiveness in the healthcare industries

One of the main tasks of the Directorate-General for Internal Market, Industry, Entrepreneurship, and SMEs is to identify key issues that affect the competitiveness of the European healthcare industries and propose solutions in cooperation with stakeholders. In particular, the DG focuses on the contribution of the healthcare industries to the European economy and the interactions between policies affecting research and development, market access, intellectual property, competition, and international trade.

Documents

Communication on the future of the pharmaceutical sector, available as part of the 2008 pharmaceutical package.

'The rules governing medicinal products in the European Union' (EUDRALEX) which contains EU legislation on medicinal products for human and veterinary use.

The Community Register which contains a list of all medicinal products for human and veterinary use, as well as orphan medicinal products, that have received a marketing authorisation through the centralised procedure.

Reports of the Pharmaceutical Committee, an advisory Committee made of senior experts from EU countries entrusted with examining questions relating to proprietary medicinal products, and in particular, the preparation of proposals for Directives.